Kornimate/medical-research-clean huggingface dataset:
diagnosis, incidence and consequences of pacu-delirium

Conditions: Postoperative Delirium; Elderly Patient; Cognitive Decline

Summary: this study aims to 1. determine sensitivity and specificity of the confusion assessment method for postanesthesia care unit (cam-pacu) 2. examine the effect of postanesthesia care unit delirium (pacu delirium) on the emergence of later onset postoperative delirium (pod) as well as cognitive recovery until one month postoperatively


Eligibility criteria:
inclusion criteria: * planned surgery in the near future * surgery time at least 60min exclusion criteria: * intracranial surgery * expected postoperative transfer to icu and stay exceeding 24h * length of postoperative stay in hospital below 24h * insufficient german language skills * current alcohol or drug misuse * manifest mental illness

Keywords: post-anesthetic care cognitive recovery delirium
nebulized colistin for hospital-acquired pneumonia

Conditions: Pneumonia

Summary: nebulized colistin for adjunctive therapy of hospital-acquired pneumonia caused by gram negative bacteria should be more effective than conventional therapy

randomized controlled clinical trial in hospitalized adult patients with hospital-acquired pneumonia. the patients are allocated to conventional group or nebulized colistin group. the conventional group receives conventional antibiotics whereas the nebulized colistin group receives nebulized colistin in addition to conventional antibiotics. the outcomes are clinical response and microbiological responses.

Eligibility criteria:
inclusion criteria: * adult (age\>18 years) hospitalized patient with hospital-acquired pneumonia due to gram negative bacteria exclusion criteria: * pregnancy * lactating woman * colistin allergy * severe renal impairment * epilepsy

Keywords: hospital-acquired pneumonia gram negative bacteria
the effect of covid-19 patients' serum phosphate level on mortality in icu

Conditions: Phosphate Deficiency; Covid19; Mortality

Summary: the investigators aimed to investigate the relationship between phosphate level and mortality using the 4c mortality score in covid-19 patients who were followed up in the intensive care unit.


Eligibility criteria:
inclusion criteria: * participants hospitalized in the intensive care unit diagnosed with covid-19 will incluse in the study exclusion criteria: * there is no exclusion criteria

Keywords: covid19 phosphate deficiency 4c mortality score
selective internal radiation therapy and 188re-sss lipiodol treatment for liver cancer (lip-re2)

Conditions: Hepatocellular Carcinoma Non-resectable

Summary: the goal of this monocentric interventional study is to evaluate the efficacy, in terms of objective response rate, of the 188re-sss lipiodol sirt in patients with non-operable hcc.

this study is an open-labelled treatment administration study conducted with an exact one-stage one-arm study plan. the study plans to included 35 patients and to treated 26 patients (take into account screen failures and sirt contraindications). the treatment is delivered by a one-day procedure leading to the injection of 188re-sss lipiodol. in details, the patient is hospitalized for one night. two steps are performed while the patient is hospitalized: the pre-treatment simulation step and the treatment step itself. after treatment, patients are followed until progression, new systemic or locoregional (in the same treatment area) antineoplastic therapy or death, within a maximum 24-month period following the sirt.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * ecog performance status 0-1 * hcc with histological diagnosis or non-invasive diagnosis according to aasld criteria * non operable and not accessible to ablation therapy * at least one measurable lesion using mrecist * tumor involvement \<50% of the liver * bclc classification a to c * compensated cirrhosis (child pugh a or b7), if cirrhosis present * registration with a social security scheme * written and informed consent of the patient or his/her legal representative exclusion criteria: * inadequate hematological, hepatic, renal, thyroid and coagulation functions: 1. hemoglobin \< 8,5 g/dl 2. granulocytes \< 1500/mm3 3. platelets\< 50 000 /mm3 4. bilirubin level ≥ 35 mol/l 5. transaminases \> 6 unl 6. creatinine \> 1,5 unl 7. tsh \< 0,2 µui/l * chronic respiratory insufficiency history * known hemophilia with exophytic tumor \> 1 cm * extra-hepatic metastasis except hilum node \< 2 cm * lung shunt \>20% evaluated with 99mtc albumin macroaggregate (maa) * poor tumor targeting with 99mtc albumin macroaggregate (maa) * previous sirt * previous systemic treatment within 4 weeks before radioembolization * more than 2 previous tace (or embolization), in the area to be treated * other neoplasia except if complete remission from at least one year * contraindication related to the technique, in particular severe arterial pathology of the lower limbs or the aorta contraindicating or making difficult an arteriography by femoral approach * pregnant woman or likely to be or breastfeeding, or male or female patients of reproductive potential without effective contraception from screening to 1 month after the end of the treatment * minors, individual deprived of liberty, or under any kind of guardianship or trusteeship. * patients unable to submit to medical follow-up of the study for social, medical or psychological reasons.

Keywords: selective internal radiation therapy 188re-sss lipiodol
emotion assessment to study consciousness in awakening patients

Conditions: Persistent Vegetative State

Summary: after a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. for some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. until now, emotions of patients suffering disorder of consciousness (doc) have been scarcely studied. it has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious. the investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness. the investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience. in order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in doc patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. the investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).


Eligibility criteria:
inclusion criteria: for patients : * age between 18 and 80 * acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month * level of consciousness assessed with the coma recovery scale revised (crs-r) * patient with health insurance * informed consent signed by the patients or his representative for healthy participants: * age between 18 and 80 * participant able to understand instructions and normal hearing * patient with health insurance * informed consent signed exclusion criteria: for patients : * non controlled epilepsy * dysautonomic crisis * unstable medical state * pregnancy or breath feeding for women * persons under guardianship, curatorship for healthy participants: * neurological disorder * pregnancy or breath feeding for women * persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty

Keywords: persistent vegetative state minimally conscious state emotions awareness electrodermal activity electroencephalography
triumph lumbar artificial disc ide: a pilot study

Conditions: Lumbar Degenerative Disc Disease

Summary: the purpose of this investigation is to evaluate the safety and effectiveness of the triumph® lumbar artificial disc for the treatment of patients who are suffering from degenerative disc disease (ddd) at one level from l1 to s1.


Eligibility criteria:
inclusion criteria: * degenerative disc disease in one vertebral level between l1 and s1 * able to understand and sign informed consent * had at least 6 months of conservative treatment * oswestry disability index score of at least 30 (one a 100 point scale) * other inclusion criteria as specified in approved ide protocol exclusion criteria: * bilateral leg pain * back or leg pain of unknown etiology * prior fusion surgery or another spinal device implanted at any other lumbar level * osteoporosis or osteopenia * other exclusion criteria as specified in approved ide protocol

Keywords: low back pain leg pain discogenic pain degenerative disc disease (ddd) herniated disc radiculopathy
a study evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients

Conditions: Hearing Loss

Summary: a feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients

the research system is comprised of several components: the processing unit, fitting software and accessories. the sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. the application of hearing aid technologies to cochlear implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for ci-alone listening, and potentially lead to efficiency in algorithm development.

Eligibility criteria:
inclusion criteria: * eighteen years of age or older * user of ci600, ci500 or ci24re implant * at least 3 months experience with a tga approved nucleus cochlear implant in at least one ear * fluent speaker of english * a word speech recognition score of 20% or more when using the cochlear implant alone\* * willing and able to provide written informed consent \*this can be based on clinical data if collected within the last 12 months exclusion criteria: * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling * cochlear employees or employees of contract research organizations or contractors engaged by cochlear for the purposes of this investigation. * current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device. (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation.
iort (intra-operative radiation therapy) in early stage breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate an investigational way to provide radiation therapy to treat breast cancer at the time of surgery. traditionally, the recommended treatment for early stage breast cancer is surgery to remove the tumor, followed by whole breast radiation therapy to decrease the chance of recurrence of the cancer. whole breast radiation involves daily radiation treatments for 4-6 weeks and can be associated with damage to other tissues including the skin. recent technological advances have made it possible to provide radiation treatment during the breast cancer surgical procedure. this procedure is called intraoperative radiation therapy (iort). the university of virginia has a unique iort system which allows for the inclusion of cutting edge imaging technology into the iort procedure in order to provide delivery of radiation directly to the needed areas and to avoid radiation to other tissues.


Eligibility criteria:
inclusion criteria: * women 50 years of age of older * patient has elected breast conserving surgical treatment for early-stage breast cancer * patient meets american society for therapeutic radiation oncology (astro) criteria for a "suitable" or "cautionary" patient * life expectancy of more than 2 years * tumor size 4cm or less * women of childbearing potential must agree to use adequate contraception exclusion criteria: * male * pregnant or nursing * any contraindication to radiotherapy * breast cancer that involves skin or chest wall, bilateral breast cancer or history of breast cancer in ipsilateral breast * patient meets any of the astro criteria for an "unsuitable" patient * patient requires chemotherapy within two weeks of iort * breast implants * a serious uncontrolled medical disorder * significant history of uncontrolled cardiac disease or cns disease
a study to evaluate the effectiveness and patient-reported outcome of adalimumab in patients with moderate to severe plaque psoriasis in china

Conditions: Psoriasis

Summary: the objective of this non-interventional, observational study is to assess the effectiveness and patient reported outcome of adalimumab in patients with moderate to severe psoriasis in real world clinical practice in china.


Eligibility criteria:
inclusion criteria: * participant who is in compliance with eligibility for adalimumab based on the local label; * moderate to severe plaque psoriasis patients eligible to use adalimumab according to the local label without any contraindication * patients have signed the authorization (or informed consent where applicable) to disclose and use personal health information after been prescribed with adalimumab. exclusion criteria: * patients who are pregnant or breast feeding at enrolment or wish to become pregnant during the following adalimumab treatment and within 150 days since adalimumab discontinuation; * patients in any psoriasis related clinical trial at the time of enrolment, at baseline or at any point during the study follow-up; * patients with active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections) as well as moderate to severe cardiac insufficiency. * patients with difficulties for adequately reading, understanding and completing patient questionnaires.

Keywords: psoriasis effectiveness safety adalimumab
bi 655066 (risankizumab) compared to placebo and active comparator (ustekinumab) in patients with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to assess the safety and efficacy of bi 655066/abbv-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

participants were randomized to receive either placebo, ustekinumab, or risankizumab in part a. all participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. participants who received placebo in part a switched to risankizumab in part b; participants who received ustekinumab or risankizumab in part a continued to receive the same treatment (ustekinumab or risankizumab) in part b.

Eligibility criteria:
inclusion criteria: * male or female patients with age ≥18 years at screening. * have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug. * have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both screening and baseline (randomisation): 1. have an involved body surface area (bsa) ≥10% and 2. have a psoriasis area and severity index (pasi) score ≥12 and 3. have a static physician global assessment (spga) score of ≥3. * must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator. * must be a candidate for treatment with stelara® (ustekinumab) according to local label. exclusion criteria: * patients with: 1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular) 2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium) 3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment * previous exposure to bi 655066. * previous exposure to ustekinumab (stelara®).

Keywords: psoriasis skin diseases skin diseases, papulosquamous ustekinumab dermatologic agents abbv-066 bi 655066 risankizumab
pediatric inflammatory bowel disease collaborative research group registry

Conditions: Inflammatory Bowel Disease

Summary: the purpose of the pediatric inflammatory bowel disease collaborative research group registry is to study the contemporary natural history of children \<16 years of age newly diagnosed with inflammatory bowel disease. the project follows these children quarterly from diagnosis examining clinical, laboratory, and humanistic outcomes. genetic and serologic monitoring is performed on the study population.

observations of children with ibd often suggest a more severe course than that found in adults. explanations for this are unclear, especially since children are less likely to engage in some behaviors (e.g., smoking) that may have a deleterious effect on disease course as noted in adults. in many ways children are a better "experimental model" of ibd because they don't have as many confounding medical factors as adults. both crohn's disease and ulcerative colitis are believed to result from a complex interaction of genetic and environmental factors (1). recently, the gene card15/nod2 on chromosome 16 has been identified in approximately 25% of caucasian patients with crohn's disease and is felt to be a significant predisposing factor to the development of fibrostenosing disease (2). additionally, seropositivity for perinuclear antinuclear cytoplasmic factor (panca) has been demonstrated much more frequently in patients with ulcerative colitis than in those with crohn's disease, while anti-saccharomyces antibody (asca) is more common in the latter population (3). the importance of these serological abnormalities is not clear, though some data suggest an influence on the development of complications. our hypothesis is that phenotypic, genotypic and serologic characteristics may provide prognostic information on response to therapy and course in children with ibd. this type of prognostic information is particularly important as newer therapies are developed.

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of ulcerative colitis, crohn's disease, indeterminate colitis 2. age up to 16 years and zero days at time of diagnosis 3. informed consent/assent from parent/guardian and patient 4. ability to be available for regular follow-up visits exclusion criteria: 1. diagnosis of ibd greater than 1 month prior to presentation to participating center 2. age greater than 16 years and zero days 3. inability to be available for regular follow-up visits

Keywords: pediatric inflammatory bowel disease multiple site study
study of losartan in the treatment of nafld in children

Conditions: NAFLD

Summary: non-alcoholic fatty liver disease (nafld) is the most common liver disease among children and is closely associated with obesity and the metabolic syndrome. nafld increases risk of mortality and natural history studies of adults show that nafld is an independent risk factor for cardiovascular disease. pediatric nafld is particularly concerning from a public health standpoint, as it represents an early and possibly more aggressive form of the disease. currently there is no effective treatment for pediatric nafld. losartan is an orally-administered angiotensin ii receptor antagonist which is currently on the market to treat high blood pressure. the renin-angiotensin-aldosterone (raa) system has been shown to be important in many disease states including renal disease, cardiovascular disease, and nafld. angiotensin antagonists are a class of medications that has been proposed as a novel treatment of nafld in part because they would treat both the factors increasing cardiovascular (cvd) risks as well as potentially improve steatosis, fibrosis and hepatic inflammation. this study is a randomized, double-blinded, placebo-controlled pilot study to evaluate whether 8 weeks of losartan will decrease inflammatory markers among children ages 12-19 with a current diagnosis of nafld. efficacy will be assessed by improvement in alanine aminotransferase (alt) from baseline. secondary endpoints will include aspartate aminotransferase (ast), cytokeratin 18 levels, and fasting triglyceride levels among others. safety will be assessed by the recording of adverse events, clinical laboratory parameters, vital signs and physical examinations.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 85th% for age and gender * history of definite or borderline nonalcoholic steatohepatitis (nash) diagnosed by liver biopsy using nash clinical research network (crn) criteria * at least 2 months of attempted lifestyle changes after liver biopsy * current alt ≥ 3 times normal (69 u/l for girls, 78 u/l for boys) at enrollment * glomerular filtration rate (grf) \> 90 * weight ≥ 62.5 kg exclusion criteria: * other chronic illness requiring daily medication (except medications for mild mental illness, acid reflux, allergies, stable attention deficit hyperactivity disorder (adhd), or asthma) * supplement or anti-oxidant therapy within past 2 weeks * renal insufficiency * cirrhosis and liver synthetic dysfunction (international normalized ratio ≥ 1.5) * history of hypotension * diabetes (or fasting glucose \> 125 mg/dl) * acute illness within past 2 weeks prior to enrollment (fever \> 100.4ºf) * pregnancy

Keywords: nafld non-alcoholic fatty liver disease obesity pediatrics children losartan cozaar
evaluation of efficacy and safety of symbicort® as an add-on treatment to spiriva® in patients with severe copd.

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Summary: the purpose of this study is to investigate the effect of combined treatment with symbicort and spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe copd.


Eligibility criteria:
inclusion criteria: * \>=40 years of age, diagnosed copd with symptoms \>=2 years, pre-bronchodilatory fev1 \<=50% of pn exclusion criteria: * current respiratory tract disorder other than copd, history of asthma or rhinitis, significant or unstable cardiovascular disorder

Keywords: chronic obstructive pulmonary disease, copd